Phenyl salicylate. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13H10O3 ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

INDICATIONS AND USAGE:

UR N-C is indicated for the treatment of
symptoms of irritative voiding. Indicated for the relief of local symptoms, such as
inflammation, hypermotility, and pain, which accompany lower urinary tract
infections. Indicated for the relief of urinary tract symptoms caused by
diagnostic procedures.

DOSAGE AND ADMINISTRATION:

FOR ORAL USE ONLY Adults: One tablet 4 times per day by mouth, followed by liberal fluid intake. Older Children: Dosage must be individualized by physician. Not recommended for use in children younger than six years.

CONTRAINDICATIONS:

UR N-C is contraindicated in patients hypersensitive to
any of its ingredients. Risk benefits should be carefully considered when the
following medical problems exist: achalasia of esophagus, atony of colon,
diseases of cardiovascular system, gastrointestinal hemorrhage; glaucoma;
hemolytic anemia from pyruvate kinase and G6PD deficiencies, infected
urolithiasis, myasthenia gravis, paralytic ileus, severe ulcerative colitis, toxic
megacolon; acute urinary retention may be precipitated in obstructive uropathy
(such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS AND PRECAUTIONS:

Do not exceed recommended dosage. This
drug may make you dizzy or drowsy or cause blurred vision; use caution while
driving, using machinery, or doing any activity that requires alertness or clear
vision. Limit alcohol consumption. Cross sensitivity and/or related problems –
patients intolerant of belladonna alkaloids or salicylates may be intolerant of this
medication also. Delay in gastric emptying could complicate the management of
gastric ulcers. There have been no studies to establish the safety of prolonged
use of this product in humans. No known long-term animal studies have been
performed to evaluate carcinogenic potential.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Hyoscyamine
sulfate and methenamine cross the placenta. Studies have not been done in
animals or humans. It is not known whether UR N-C tablets cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
UR N-C tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Problems in humans have not been documented; however,
methenamine and traces of hyoscyamine sulfate are excreted in breast milk.
Accordingly, UR N-C tablets should be given to a lactating woman only if clearly
needed. Discuss the risks and benefits with your doctor.

Pediatric Use:

Infants and young children are especially susceptible to the toxic
effect of the belladonna alkaloids (hyoscyamine sulfate). This product contains
salicylate, which is related to aspirin. Children and teenagers should not take
aspirin, aspirin-containing or aspirin-related medications if they have
chickenpox, influenza, or any undiagnosed illness without first consulting a
doctor. A rare but serious illness known as Reye’s syndrome may occur. This
medication is not recommended for children younger than 6 years.

Geriatric Use:

Kidney function becomes impaired with age. This medication is
removed by the kidneys. Therefore, use with caution in elderly patients as they
may respond to usual doses of hyoscyamine sulfate with excitement, agitation,
drowsiness or confusion.

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. The following number does not provide medical advice, but in the U.S. you may report suspected side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

This drug should not be used with the following
medications because very serious interactions may occur: live influenza virus
vaccine, pramlintide. Because of this product’s effect on gastrointestinal motility
and gastric emptying, it may decrease the absorption of other oral medications
during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause
the urine to become alkaline reducing the effectiveness of methenamine by
inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may
intensify antimuscarinic effects of hyoscyamine sulfate because of secondary
antimuscarinic activities of these medications); antacids/antidiarrheals (may
reduce absorption of hyoscyamine sulfate, concurrent use with antacids may
cause urine to become alkaline, reducing effectiveness of methenamine by
inhibiting its conversion to formaldehyde). Doses of these medications should
be spaced 1 hour apart from doses of hyoscyamine sulfate; antimyasthenics
(concurrent use with hyoscyamine sulfate may further reduce intestinal motility);
ketoconazole (patients should be advised to take this combination at least 2
hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent
use may intensify antimuscarinic side effects), opioid (narcotic analgesics may
result in increased risk of severe constipation); sulfonamides (these drugs may
precipitate with formaldehyde in the urine, increasing the danger of crystalluria).
This is not a complete list of all drug interactions. Tell your doctor or pharmacist
of all prescription medications prior to use.

DRUG ABUSE AND DEPENDENCE:

A dependence on the use of UR N-C has
not been reported nor expected based on the pharmacology of the ingredients
contained in UR N-C.

OVERDOSAGE:

By exceeding the recommended dosage of UR N-C,
symptomology related to the overdose of its individual active ingredients may be
expected as follows:

Hyoscyamine sulfate: Symptoms associated with overdosage of UR N-C will
most probably be manifested in the symptoms related to overdosage of alkaloid
hyoscyamine sulfate. Such symptoms as dryness of mucous membranes;
dilation of pupils, hot, dry, flushed skin; hyperpyrexia; tachycardia; palpitations;
elevated blood pressure; coma; circulatory collapse and death from respiratory
failure can occur due to overdosage of these alkaloids.

Methenamine: If large amounts of the drug (2-8 g daily) are used over
extended periods (3-4 weeks), bladder and gastrointestinal irritation, painful and
frequent micturition, albuminuria and gross hematuria may be expected.

Phenyl salicylate: Symptoms of phenyl salicylate overdosage include burning
pain in throat and mouth, white necrotic lesions in the mouth, abdominal pain,
vomiting, bloody diarrhea, pallor, sweating, weakness, headache, dizziness and
tinnitus. The symptoms, however, are not expected to be discernible from those
associated with the other active ingredients in UR N-C.

Methylene blue: Symptoms of methylene blue overdosage associated with the
overdosage of UR N-C are not expected to be discernible from those associated with other active ingredients in UR N-C.

Treatment: Emesis or gastric lavage. Slow intravenous administration of
physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as
needed in one to two hours to reverse severe antimuscarinic symptoms.
Administration of small doses of diazepam or baclofen to control excitement and
seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate re-hydration is required. Symptomatic treatment as determined by a
doctor.

If overdose is suspected, contact your local poison center or emergency room
immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

CLINICAL PHARMACOLOGY:

Hyoscyamine sulfate: Hyoscyamine sulfate is a parasympatholytic which
relaxes smooth muscles and thus produces an antispasmodic effect. It is well
absorbed from the gastrointestinal tract and is rapidly distributed throughout the
body tissues. Following oral administration, the drug has an onset of action of
20 to 30 minutes. The half-life is 3.5 hours. Hyoscyamine is distributed
throughout the body, crosses the blood-brain barrier, and is approximately 50%
bound to plasma proteins. It is metabolized in the liver to tropic acid, tropine,
and hyoscyamine glucuronide. Hyoscyamine is excreted primarily unchanged in
the urine within 12 hours. Its biotransformation is hepatic.

Methenamine: Methenamine, after oral administration, undergoes hydrolysis
and generates formaldehyde, which provides bactericidal or bacteriostatic
action. Methenamine is rapidly absorbed from the intestinal tract and is
excreted, for the most part, unchanged in the urine at which point it is
hydrolyzed if the urine is acidic. It is almost completely excreted (90%) in the
urine within 24 hours; of this at a pH of 5, approximately 10-30% is converted to
formaldehyde in the stomach.

Phenyl salicylate: Phenyl salicylate, a form of salicylic acid, is a mild analgesic
for pain relief.

Methylene blue: Methylene blue is a monoamine oxidase inhibitor with weak
antiseptic properties. It is well absorbed by the intestinal tract and rapidly
reduced to leukomethylene blue, which is stabilized in the urine. Approximately
70-80% is excreted unchanged in the urine.

HOW SUPPLIED:

UR N-C is available as a purple tablet, imprinted “293”:
bottles of 100 tablets, NDC 51862-175-01. Dispense in a tight, light-resistant
container as defined in the USP/NF with a child resistant closure. Store at
controlled room temperature 15°-30°C (59°- 86°F). Keep in a cool, dry place.

WARNING: Keep this and all drugs out of reach of children.
Caution: Rx Only